The Open Medicine Institute: Big Plans and a Sense of Urgency

July 1, 2013

by Sasha

Imagine that you’ve just been put in charge of the world’s ME/CFS research – yes, you – and you’ve got to decide what research you want. Come on, hurry up!

Erm, erm, erm… oh yes, well, of course, as a patient you want something that’s going to get practical benefit for you in the shortest time possible. You’ve been waiting decades for treatments: you want them fast. But you’re not some medical genius so how are you going to choose what research should be done? Well, you could get the best ME/CFS researchers in the world, shove them in a room together and not let them out until they’ve come up with a list of the best, fastest-payoff, top priority projects, and… hang on a minute, somebody’s just done that.

In June 2012, the brand-new Open Medicine Institute, founded by well-known ME/CFS clinician and researcher Dr Andreas Kogelnik, held a three-day conference of leading ME/CFS researchers from all over the world. Attendees and signatories were a roll-call of our best and brightest, including Drs Klimas, Fluge and Mella, Peterson, Singh, Lapp, Bateman, Montoya, Marshall-Gradisnik, Rowe, Alan and Kathleen Light, and many more.

OMI-MERIT Priority Projects

The remit of the conference was to come up with a list of research projects that would deliver practical benefits for patients in the fastest possible time. Here’s the list, in order of priority (if you can’t cope with this much detail, skip to the end of the list where I give you the highlights; conversely, if you’d like more detail, go here):

1. Large-scale, randomised, placebo-controlled trial of Rituximab and Valganciclovir (Valcyte) – $7.65 million (£5.1 million, €5.9 million)This trial would be on a larger scale than the Haukeland study and would explore the possibility that it’s necessary to not only ‘reboot’ our immune system B-cells with Rituximab, but also clear the decks of viruses with Valcyte. As with any immune therapy trial, success here would both provide treatment for patients and help move ME/CFS into the medical mainstream.

2. International neuro-registry and biobank – $1.93 million (£1.3 million, €1.5 million)A biobank of blood, cerebrospinal fluid, urine, stool, brain and central nervous system tissue and other samples will be collected both from patients and controls, along with data on symptoms. Cutting-edge tools in immunology, genomics and molecular biology will be used to establish clinical and biologic clusters in the population, paving the way for diagnostic biomarkers and cluster-specific treatments.

3. Protein panel in treated and untreated patients – $658,000 (£436,000, €509,000)Specimens will be selected from the biobank based on expected yield from clinical data and subjected to protein analysis to identify bacteria, viral, hormonal, antibody, cytokine and other protein-based substances that might be present in patient specimens. Protein markers are key in identifying potential biomarkers, and many new advanced detection technologies that have never been applied to ME/CFS before will be used here. Discoveries will be confirmed in the larger patient population.

4. Treatment: Phase 2: Other mono- and combination-therapy pilots – $984,000 (£652,000, €761,000)This project will assess, via pilot studies, the effect of other currently available treatments such as Ampligen, Etanercept, Rifaximin, Isentress and Famciclovir, and will establish immunologic and molecular parameters for measuring the efficacy of such treatments. This will help identify which drug therapies should be prioritised for further research.

5. Immunologic biomarker exploration studies – $447,000 (£296,000, €346,000)These exploratory studies will examine B-cell, T-cell and Natural Killer cell responses in treated and untreated patients using comprehensive, rigorous methods, many of which have never before been applied to ME/CFS.

6. DNA genetics – $592,000 (£392,000, €458,000) Advanced Human Genome Project technologies will be used to sequence key genome areas – including methylation genes – in a set of patients, controls, affected families and unrelated individuals. The goal is to establish or refute a role for genetics and potential heritable risk in ME/CFS.

7. Mass spectroscopy/environmental measurements – $232,000 (£154,000, €179,000)This exploratory study will search patient samples for unknown compounds, toxins, proteins and other substances to see if nutritional and environmental factors are implicated in the genesis of the disease or otherwise contribute to immune dysfunction.

8. Comprehensive viral testing – $406,000 (£269,000, €314,000)This study aims to establish a gold standard of clinical viral testing in ME/CFS. Testing will include blood, urine, saliva and other tissues where available for specific viruses such as EBV, HHV-6, CMV, Parvovirus, HSV-1 and HSV-2 as well as testing for novel viruses.

10. Treatment: Phase 3: Natural and over-the-counter substances – $416,000 (£276,000, €322,000)This project will be the first application of vetted scientific methods and molecular science to non-pharmacological substances that have had anecdotal benefits for people with ME/CFS, including Moringa oleifera, GcMAF, Vitamin B12 and Artemesinin.

Click the image for a video of interviews with the OMI’s team

From a patient’s point of view, that’s a very interesting list. On treatments, at one end it has studies on the heavy-duty immune drugs such as Rituximab, Valcyte and Ampligen: if any such study was successful it would not only help make those treatments available but would have a huge knock-on effect in validating our disease as an immune-system one. At the other end, there are treatment studies on non-prescription substances that we can get our hands on now, such as GcMAF and B12. All of these treatments are hot topics in the patient community.

The list also contains studies applying cutting-edge laboratory techniques to look at biomarkers, pathogens, toxins and genetics and includes all the major items of interest to patients – herpes viruses, NK cells, methylation, you name it. ‘Cutting-edge’ is a phrase that keeps coming up with the OMI – they want to use the most advanced technology to get at the heart of this most complex of diseases.

Plug in to the Network

They’re also keen on collaboration and opensourcing. Dr Kogelnik’s background is in bioengineering, molecular biology, genomics, immunology and bioinformatics – he’s well placed both on the science side and on how to get the most out of collecting, analysing and sharing the huge amounts of data needed to solve the ME/CFS problem. OMI will soon be opening Open Mednet, an online data repository where patients anywhere in the world, hopefully in their tens of thousands, can contribute to this research. We’ll be covering this in a future article: you can pre-register for the project now.

OMI’s collaborative, outreaching strategy has shown up not just in assembling the impressive panel of collaborators who drew up the priority research list, but as a networking approach that ranges from bagging a top-ranking researcher such as Dr Jay Levy – co-discoverer of HIV – to serve on the OMI’s board, to generously using OMI’s own Facebook page to support a patient, Dr Maria Gjerpe, in her fundraising efforts for a Rituximab trial in Norway.

Dr Andreas Kogelnik, founder and director of the OMI and Linda Tannenbaum, executive director of the OMF

Fundraising

The full whack to fund all of the studies is $13.5 million (£9.0 million, €10.4 million): peanuts for a government, a lot of money for ME patients to get together. Can the OMI raise it? Well, they’ve already bagged cash or pledges of $1.8 million (£1.2 million, €1.4 million). Although donations to the general pot go by default to the highest priority study, donors can specify where they want their money to go and two projects are already fully funded: the Neuro-Immune Disease Alliance have paid $40,000 (£27,000, €31,000) for a study on over-the-counter treatment Moringa oleifera (part of Project 10) and the Edward P. Evans Foundation have covered Project 6, the genetic study. An individual patient has donated $100,000 (£66,000, €77,000) to Project 1 – the Rituximab/Valcyte study.

The OMI are industriously tapping up every possible source of funding: foundations, individuals, corporations, pharmaceutical companies, diagnostic companies and the government. They’re starting to get traction on most of these and are taking ‘in kind’ donations as well as cash. For example, the OMI were just awarded a grant of both financial and consulting support by VMware, a virtualisation and cloud infrastructure company.

The OMI’s fundraising arm, the Open Medicine Foundation (OMF) are, incidentally, legit! A forum member asked a question on the boards a while back about their tax and charity status. The OMF are a legal 501(c)(3) nonprofit with effect from 31 July 2012 but since they had no activity for three years prior, the IRS revoked that status until they had activity and refiled. The Foundation are new so there is no 990 form yet. They can be seen on both the IRS and Guidestar sites.

So: big ideas, highly efficient use of samples and data, cutting-edge science and they’re not mucking about. Want to make a donation? The OMI do research on other diseases so when you go to their donation page, be sure to check the ‘ME/CFS Research (MERIT Initiative)’ option. If you’d like your donation to go to a specific project, say so in the ‘Message to honoree’ box.

You can keep in touch with the OMI’s activities via their free newsletter (sign up here). They have plenty more in the pipeline and are well worth watching!

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I would like to see Open Medicine do a study in which they use the ERMI test to evaluate the relative moldiness of the homes of patients who are still living in the same place where they got sick. If (as I believe will be the case) the homes come up as being particularly moldy, then this would establish living in a moldy home as a risk factor for acquiring the disease.

This would be a relatively low cost study, and I have funding lined up from a wealthy entrepreneur who has an interested in mold illness and CFS. So far though, I've struck out at trying to get the people involved in Open Medicine to take mycotoxins seriously.

Hi Lisa – It must be very frustrating to be holding a big bag of cash for a project that you want done and not to be able to get it underway! I wouldn't expect OMI to be 'for hire' like that, though – they've drawn up a priority list of research based on their conference of experts and they're working through it as fast as they can get those topics funded. The project you're suggesting isn't on that list and didn't undergo that process of consultation and prioritisation.

And additional thanks for the (hopefully) clarified position pertaining to charity status. Donors will be reassured about that I am sure. At least you should be able to legitimately claim your tax back on any donations.

Last time I checked there wasn't a great deal of detail about these proposed studies – other than the designation and fundraising desire – on their website; but I will check again later. It will be hard to organise the e.g. Rituximab study I suspect but that doesn't mean they shouldn't try. And others e.g. Invest in ME in the UK, are going about it in the same manner i.e. raising funds before having the specifics ironed out. Of course it would make me personally more comfortable if the cart had been placed before the horse – but that's just me.

I remain cautious however about Kogelnik simply because he is treating patients with Rituximab outside of any registered clinical trial or registered pilot. But that's just me and I don't really want to get into that. We did all of that on a previous thread. I'd be interested in learning some more about the team he has working with him at the Institute on a daily basis – the personnel and the infrastructure at some point.

Ember flagged a $1 million donation to OMI back in May, from the Edward P. Evans Foundation for that genetics study. Although it would suggest the cost of that project is significantly more than you have listed above? Though perhaps not all of it went to the one project. I don't know it was a while ago now. But at least then one project is fully funded. I wonder what the situation is now? Maybe there is some news on their website.

"A biobank of blood, cerebrospinal fluid, urine, stool, brain and central nervous system tissue and other samples will be collected both from patients and controls…"

It seems like a comprehensive list of tissue types!

Good spot, Bob and co. This is interesting as I have literally finished transcribing a talk connected to the proposed UK post-mortem tissue bank. One of the things discussed was the feasibility the practicality and ethics of brain biopsy; hence the need identified for a post-mortem bank. You can do live brain biopsy – but they are risky and require general anaesthetic of course. Also I am not sure (because I am a prat with no medical knowledge!) what use tissue that is able to be extracted from a live brain could be to ME science… Now if it was a post-mortem bank they were proposing, well I can see how that might be feasible: and a first for the USA if I am not mistaken.

Thanks for a great article, Sasha. I am always amazed by the OMI's ambition, and their ability to pull in the big players in ME/CFS research.

OMI

8. Comprehensive viral testing – $406,000 (£269,000, €314,000)This study aims to establish a gold standard of clinical viral testing in ME/CFS. Testing will include blood, urine, saliva and other tissues where available for specific viruses such as EBV, HHV-6, CMV, Parvovirus, HSV-1 and HSV-2 as well as testing for novel viruses.

Bit puzzled by this, which seems to be covering the same ground as the larger ($) Mady Hornig/Lipkin pathogen study – hard to think they will do better than Hornig and Lipkin at virus detection… The OMI do mention other samples beyond blood, while the Hornig study is just using blood, and for some Cerebro Spial Fluid at this stage, though they hope to add more tissues later.

Bit puzzled by this, which seems to be covering the same ground as the larger ($) Mady Hornig/Lipkin pathogen study – hard to think they will do better than Hornig and Lipkin at virus detection… The OMI do mention other samples beyond blood, while the Hornig study is just using blood, and for some Cerebro Spial Fluid at this stage, though they hope to add more tissues later.

Various groups intend to carry out Rituximab research as well, before Fluge and Mella have completed their larger study.
I suppose they think that more good-quality research can only be a good thing, if carried out in areas that they think will be productive.
Replication isn't harmful, after all.

Though really a replication needs to be careful to use the same methodology, or be explicit in why it is taking a different approach. Otherwise you can get, all too frequently, researchers asking similar questions but getting different answers where it's not clear if the difference is down to methodology – so nothing gets confirmed or replicated.

Last time I checked there wasn't a great deal of detail about these proposed studies – other than the designation and fundraising desire – on their website; but I will check again later. It will be hard to organise the e.g. Rituximab study I suspect but that doesn't mean they shouldn't try. And others e.g. Invest in ME in the UK, are going about it in the same manner i.e. raising funds before having the specifics ironed out. Of course it would make me personally more comfortable if the cart had been placed before the horse – but that's just me.

Hi Firestormm – I'd assume the OMI projects have been fully costed (the costs are pretty specific) and hence have fairly detailed protocols behind them – I wouldn't expect full protocols to go up on a fundraising website, though. The Rituximab/Valcyte study is very expensive and I'm assuming that the OMI is going after the government and other big institutions for that one – they'd need a full protocol for that.

IiME, on the other hand, have been explicit in stating that they don't yet have a protocol or a costing or (I think) any researchers or institutes on board for sure – they're intending to put those details up once they've been hammered out. I don't think that's the same as what the OMI are doing. I agree that there's a bit of a horse/cart issue with the IiME project and I look forward to seeing more detail. It's a very exciting project for us in the UK especially and I'd like it to succeed. Once they get more detail out, I'd hope to see an acceleration in support.

"A biobank of blood, cerebrospinal fluid, urine, stool, brain and central nervous system tissue and other samples will be collected both from patients and controls…"

Hopefully, with these brain tissue samples, the researchers will look to see which viruses have invaded the brain, and perhaps, like one previous brain autopsy on an ME/CFS patient, confirm that the glial cells of the brain are infected with enteroviruses.

Hopefully, with these brain tissue samples, the researchers will look to see which viruses have invaded the brain, and perhaps, like one previous brain autopsy on an ME/CFS patient, confirm that the glial cells of the brain are infected with enteroviruses.

OMG, what a tragic story. This piece about wrong assumptions is so powerful and true and should be installed in neon lights in all the psychoquacks' offices:

"That if there is no concomitant illness definable by the doctor, then it must be all in the mind. Varying hypotheses have been put forward to explain this. None of these are really convincing to those of us who have worked in the field for many years, and indeed cause us considerable distress, though this must be minimal compared to the distress felt by the patient when the effects of the illness are compounded by a negative approach, sometimes amounting to a denial of the illness itself. This has resulted in suicides in some cases, and the very act itself is then seen as verification of the original "all in the mind" diagnosis."

Indeed. The author of the brain autopsy study, Dr John Richardson, was a GP in Yorkshire, UK, and 50 years ago Richardson helped lay the foundations for the enteroviral theory of ME/CFS.

In those early days, 50 years ago, the psychoquacks had not yet got a hold of ME/CFS, and Richardson's repeated observations that ME could appear following a coxsackievirus infection was a leading theory for this illness. Those were the days when this illness was only called myalgic encephalomyelitis.

But once the psychoquacks came on the scene, the coxsackievirus cause of ME/CFS was clouded and lost in the fog of all the psychobabble than ensued.

I personally think that the coxsackievirus/enterovirus theory of ME/CFS is still the original and best. I am at a loss to understand why there is so little focus on enterovirus research. Only in the last 15 years has Dr John Chia taken up the enterovirus baton, and continued where Richardson left off. But Dr Chia is more-or-less the only researcher in the field interested in enteroviruses. This is ridiculous. There should be dozens of scientists looking at enterovirus etiologies of ME/CFS.

I know others are undertaking or attempting to undertake Rituximab studies elsewhere. But those have not even started yet. We are so, so far from having trialled Rituximab adequately. It seems premature to run a trial on Rituximab + Valganciclovir when the need for study of Rituximab alone is still so desperate.

Perhaps if the study was designed with three arms: control group, Rituximab, and Rituximab + Valganciclovir, it might be more revealing – and might help contribute toward sorting out the question of whether there are subtypes with active viral infection and subtypes without, and how best to identfy those subtypes. (Actually I don't know if the study is in fact designed that way – is it?) It seems to make more sense than studying the R+V combination and then not knowing at study's end how the combination compares to R alone.

Well, shut mah mouth, I should have clicked on the "for more information" link before I started pontificating. It is in fact a FOUR-armed study – control, R alone, V alone, and R+V in the fourth arm. It says "large-scale" but does not specify the exact size of the trial. For $7.65 million I'd expect it must be fairly large.

Well, shut mah mouth, I should have clicked on the "for more information" link before I started pontificating. It is in fact a FOUR-armed study – control, R alone, V alone, and R+V in the fourth arm. It says "large-scale" but does not specify the exact size of the trial. For $7.65 million I'd expect it must be fairly large.

Yes, I think it will be larger than the Haukeland study and it's designed partly to test the hypothesis that it's not enough to wipe out the B-cells, it's necessary to reduce viral load, hence the Valcyte.

Thanks for this article, I found it very exciting. Wow what a great list of studies they want to do!!

Im very happy the methlyation gene study has been funded for as I personally believe that affects many of us and Ive found treating my MTHFR polymorphism to be quite beneficial. I I believe there must be more of those who carry this gene compared to the general healthy population as it can cause a lot of issues.

@Sasha – I was a little slow in finding the article you wrote, but nice job on getting this information out. Dr. Kogelnik is my doctor and I didn't even know all the things that you covered in this article. :wide-eyed: Thank you. :thumbsup:

@Sasha – I was a little slow in finding the article you wrote, but nice job on getting this information out. Dr. Kogelnik is my doctor and I didn't even know all the things that you covered in this article. :wide-eyed: Thank you. :thumbsup:

So was I slow! It took a bit of digging – it was a while ago now. It's a great initiative. I'm glad you found some new stuff!

I count$ 13 million for high tech toxins and $400k for "anecdotal" over the counter stuff (like b12). This plan is down the toilet from the begining.they're going to cure a Disease of Civilization (Google Kurt Harris MD-he's one of them and he knows it's a crock of shit!) with more toxic synthenic substances. Wow! Did I miss the part about Diet, Toxins,EMF"s, LIFESTYLES. Let them just give Freddd and Radio a $100 grand to take over the whole project and take the rest of the $13 to Vegas! How do you say "pissing money away" in other countries?

:)Sorry I did not see $600 k for Genome research. So I will amend my Statistical analysis. $12.4 MILLION FOR HIGH TECH CRAP and $1 MILLION FOR SOMETHING "SOMEWHAT" NATURALTHAT COULD WORK. We are up to 8%. I see a "cure" any day now. Don't you?

I count$ 13 million for high tech toxins and $400k for "anecdotal" over the counter stuff (like b12). This plan is down the toilet from the begining.they're going to cure a Disease of Civilization (Google Kurt Harris MD-he's one of them and he knows it's a crock of shit!) with more toxic synthenic substances. Wow! Did I miss the part about Diet, Toxins,EMF"s, LIFESTYLES. Let them just give Freddd and Radio a $100 grand to take over the whole project and take the rest of the $13 to Vegas! How do you say "pissing money away" in other countries?

People do research they think is important and other people donate to programs they think are valuable. Who are you to judge?

I suggest if you have THE ANSWER, rather than criticizing other people's choices with nasty language, you set up a research program yourself. Find the right researchers, do the necessary fundraising, and prove your answer is a cure for ME/CFS. That would be way more useful than coming on PR and ragging on researchers trying to help us.

I am sorry that I brought such anger out in you. My point was to point out , poisons will not cure poisoned people. Being human is the only chance we victims of Civilization will have to be cured. Many modalities for cure are already being used by people on PR. Its just so very few are listening. The resarch on diet, methylation, resistant starch, et all all have threads here. Just very few are interested in trying them. There is very little reason to raise funds. Potato starch is under $3 a lb. Just try it. Peace

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